Shawn Cain, senior VP of development and manufacturing, discusses pharma and biopharma outsourcing trends.
With the technologies needed to handle today’s complex therapies, such as biologics, highly potent drugs, and specialty drugs in patient-centric delivery systems, Contract Development and Manufacturing Organizations (CDMOs) such as PCI Pharma Services, provide access to both experience and expertise, while helping to speed time to market. Sponsors increasingly seek more strategic relationships with CDMOs to help reduce supply chain complexity and risk.
First published in Contract Pharma, May, 2022
PCI Pharma Services provides preclinical and clinical drug development services for investigational medicines, while offering flexibility and custom solutions at every stage of the cycle. Shawn Cain, Senior Vice President of Development and Manufacturing at PCI Pharma Services, discusses the pharma and biopharma trends driving opportunities and outsourcing in today’s market, and the industry’s outlook for the next few years.
Contract Pharma: What are the pharma and biopharma trends driving opportunities and outsourcing in today’s market?
Shawn Cain: Historically, the parenteral manufacturing industry was a more fragmented market with different companies perhaps specializing in certain aspects of the supply chain. More recently, pharmaceutical companies are looking to identify potential CDMO partners who truly provide a full end-to-end solution, while maintaining the unique ability to be flexible for challenging manufacturing processes. To help reduce supply chain complexity and risk, clients want to manage as few partners for a single program as possible, meaning a CDMO able to provide services from early stage development to clinical and commercial manufacturing and packaging, with full analytical support including ICH stability testing and final distribution is an attractive proposition.
This became evident during the pandemic when CDMOs supported the production needs of their client’s aggressive timescales. This often included investment in new technologies, such as increasing cold chain capabilities and capacity and providing additional services to mitigate risk.
PCI’s acquisition of Lyophilization Services of New England, Inc. (LSNE) supports this strategic approach. The addition of LSNE cements PCI’s reputation as a leading global CDMO providing an integrated solution to clients across the entire drug product lifecycle, from development to commercialization, meeting the needs of pharmaceutical companies and bringing life-changing therapies to patients faster.
CP: In what service areas do you see the most growth?
Cain: We continue to see a growing demand for lyophilization technology in support of parenteral products. The boom of biologics versus small molecule pharmaceuticals has also impacted the traditional approach for sterile fill-finish services. Due to the stability challenges of many biologics, lyophilization is essential to improve stability and reduce the complexity associated with cold chain logistics. Vaccines and anti-viral products are perfect examples of the challenges involved in liquid presentations that lack stability and require specialist cold chain packaging, storage and distribution solutions.
The prefilled syringe sterile filling market is also seeing continued growth due to the benefits associated with such delivery formats. Prefilled syringes can not only save valuable drug product by reducing waste by eliminating overfilling, they also help to reduce dosage errors that can be a common issue with the more traditional vial dosage systems.
As a result, pharmaceutical companies continue to search for CDMOs with the technologies for this type of manufacturing and, most importantly, the experience and expertise to advise on the most suitable delivery system depending on patient needs.
CP: What are some of the latest motivators for sponsors with respect to outsourcing in today’s market?
Cain: The market drivers motivating outsourcing continue to be start-up costs, which are particularly important for small and mid-sized pharmaceutical and biopharmaceutical companies, that may have limited or even no in-house capacity. Their biggest challenge is accessing the funds for the capital investment to manufacture in-house. Also of paramount importance is speed to market. Readily available capacity at a specialist CDMO enables a faster route to the delivery of these often lifesaving drug products to patients in a more time-efficient way than developing the internal capability.
In addition, leveraging the expertise of CDMOs specializing in lyophilization and sterile fill-finish manufacturing means access to a vast pool of knowledge. Considering the broad range of projects that such a CDMO is exposed to, creates a wealth of experience in terms of product processing and the associated quality and regulatory requirements, ultimately providing clients with added assurance that their strategy is viable.
CP: What are some of the current market challenges for drug development?
Cain: As we emerge from the COVID-19 pandemic, we are facing the challenge of global supply chain disruption with shortages of both raw materials and consumables. As global suppliers experience workforce shortages and interruptions in their ability to source API/BDS and consumables, the downstream ramifications for pharmaceutical companies developing new and innovative therapies inevitably means delays. With the last two years being focused on COVID-19 vaccine development, the development of new therapies to treat other conditions has also been somewhat delayed.
To overcome some supply chain challenges, pharmaceutical companies and CDMOs alike are now looking to source API and consumables from domestic suppliers, which not only helps reduce the company’s carbon footprint but can also assist in reducing lead times. However, these benefits tend to come with higher pricing meaning companies are facing the ultimate decision of cost versus time.
Cost and time efficiencies can be achieved with supply chain foresight. At PCI, we have navigated potential supply chain challenges by utilizing our integrated and predictive supply chain management platform, pci|bridge™. Utilizing this innovative technology, we were able to work with our clients, adjust forecasts, order additional supplies and leverage existing relationships and partnerships to source materials.
CP: What capabilities are needed for today’s complex therapies?
Cain: Today’s technologies are increasingly complex. CDMOs must therefore meet the challenge by providing their clients with a high level of expertise, such as the ability to formulate and fill a variety of complex processes, with scalable development and manufacturing solutions delivered in a quality-driven, cost- and time-efficient manner.
At PCI, we have noticed an increased demand for the formulation of Lipid Nanoparticles (LNPs), aseptic ball milling, self-assembling polymer particles for controlled release products, and APIs that require organic solvent lyophilization. The technical transfer to GMP manufacture of these complex processes can often require multiple engineering runs and process-specific media fill validation programs.
Where possible, CDMOs should use disposable product contact manufacturing materials, firstly to reduce the risk of any potential cross contamination, and secondly to eliminate the need for time-consuming and expensive cleaning procedures and validations. The product lifecycle stage should also be considered, to ensure that any processes or analytical methods are developed to the appropriate validation. The engineering team should ensure the aseptic process is scalable and will maintain compliance through the development stage to commercial manufacture of the product, as these products require strong process engineering capabilities.
To meet the demands of a dynamic marketplace, CDMOs need to be collaborative and creative, with the ability to provide their clients with a tailored service. Whether it be for complex formulation process development, scale up, technology transfer or bespoke packaging of biologic drug products, this approach allows CDMOs to deliver flexible, agile and timely solutions to help bring life-changing therapies to patients.
CP: What are your thoughts on the industry’s outlook for the next few years?
Cain: The pharmaceutical industry is increasingly developing more biologic products than ever before. However, they are unlikely to replace their small molecule drug product counterparts with dual drug therapy strategies, a clear option to provide the right treatments for the right patients. Whether large or small, molecules are becoming more complex with a clear focus on developing targeted, specialty drugs in patient-centric delivery systems.
The increasing trend of personalized medicine and treating orphan designated diseases will continue, meaning more niche products and smaller batch sizes, with increasing pressure on delivering speed to market. To meet these growing market needs, CMDOs must provide a flexible, integrated approach to scalable development and manufacturing to deliver these specialized products to the market in the most cost and time efficient way.
In terms of outsourcing, pharmaceutical companies will continue to consolidate their third-party suppliers, seeking more strategic relationships to help reduce supply chain complexity and risk. Successful CDMOs will have integrated end-to-end global solutions for small and large molecules, with the ability to develop, manufacture and pack many dosage forms meeting client clinical and commercial needs to deliver life-changing therapies to patients.
After multiple years of intense focus in combatting a pandemic, we can expect more consistency and return to pre-pandemic timelines. Companies that adapt and provide comprehensive end-to-end services with quicker timelines will continue to lead the market, especially if they are able to provide a dedicated project management point of contact for the client and expedite the products’ development lifecycle.